A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

To join this study, people need to be between 55 and 90 years old and have a confirmed diagnosis of Alzheimer's disease. This diagnosis needs to be backed up by specific medical tests, such as special brain scans or blood/spinal fluid tests that look for signs of Alzheimer's.

Participants also need to be experiencing agitation, which means they feel restless, upset, or sometimes aggressive. This agitation must have started at least two weeks before the study begins and be significant enough to meet certain criteria set by the researchers. Their memory and thinking skills, checked by a simple test called the MMSE, should be within a specific range.

Finally, a key requirement is having a main caregiver who spends at least 10 hours a week with the participant. This caregiver must be willing to attend all study visits, help ensure the participant takes their medication correctly, and provide information about how the participant is doing throughout the study.

If you decide to take part, you'll have regular visits to the study clinic. These visits will involve various assessments, like answering questions about how you're feeling and your memory, and doctors will check your overall health. You will also be given either the study medication (KarXT + KarX-EC) or a placebo, which you'll need to take as directed. Your caregiver will play a vital role in helping with these visits and making sure the medication is taken correctly. The study will run for a specific period, and you'll have follow-up checks even after finishing the main treatment period to ensure your well-being. The total duration of participation will be explained to you in detail.